Trial reportBMC infectious diseases2016
Evaluation of SD Bioline HIV/syphilis Duo rapid test kits in Nepal.
Trial report in BMC infectious diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A systematic review and meta-analysis of studies evaluating the performance and operational characteristics of dual point-of-care tests for HIV and syphilis.Sexually transmitted infections · 2017Pooled it
- Diagnostic performance evaluation of the Abbott Bioline™ HIV/Syphilis Duo rapid test at the national public health laboratory, Yaounde-Cameroon.BMC infectious diseases · 2026Article
- Feasibility, Preference, and Impact of a Rapid Multiplexed Point-of-Care Digital Innovation (AideSmart!) to Expedite Screening of Sexually Transmitted Blood-Borne Infections in At-Risk Populations in Canada: Cross-Sectional Study.Journal of medical Internet research · 2024Article
- Article
- Laboratory assessment of SD Bioline HIV/Syphilis Duo Kit among pregnant women attending antenatal clinic Mayuge Health Center III, East central Uganda.BMC research notes · 2019Article
- Laboratory evaluation of four HIV/syphilis rapid diagnostic tests.BMC infectious diseases · 2019Article
- Diagnostic Performances of Three Rapid Diagnostic Tests for Detecting HIV Infections in Mali.Infectious diseases diagnosis & treatment · 2019Article
- Expanding syphilis testing: a scoping review of syphilis testing interventions among key populations.Expert review of anti-infective therapy · 2018Article
- Field evaluation of SD BIOLINE HIV/Syphilis Duo assay among pregnant women attending routine antenatal care in Juba, South Sudan.PloS one · 2018Article
- Elimination of mother-to-child transmission of HIV and Syphilis (EMTCT): Process, progress, and program integration.PLoS medicine · 2017Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAccurate and prompt diagnosis of HIV and syphilis simultaneously has reinforcing effect on their control program because of their prevalent co-infection. Availability of a simple user-friendly two-pronged and affordable detection tools brings down the cost of health care. They are important in the antenatal clinics, with added opportunity for intervention and prevention of mother to child transmission. In cooperation with rapid test kit manufacturers, SD Bioline, NPHL and NCASC, an evaluation of commercially available HIV/syphilis Duo rapid test kit (SD Bioline) to assess its performance and operational characteristics was done in the present study.
methodA prospective laboratory-based cross sectional study was conducted at a large Women's Hospital. Ten thousand pregnant women, visiting the Hospital for antenatal care or for delivery, were enrolled in study. Tests were performed by the SD Bioline HIV/Syphilis Duo kit as well as national algorithm for HIV and syphilis diagnosis which were considered gold standard. Sensitivity, Specificity, positive predictive value and negative predictive value along with kappa coefficient were calculated for the kit under evaluation.
resultThe sensitivity, specificity, Negative predictive value and Positive predictive value of the kit for HIV diagnosis were 100 % (95 % CI 83.18-100 %, 99.96-100 %, 83.18-100 %, and 99.96-100 %, respectively). Kappa value was found to be 1.0. Out of total cases, results of 9985 (99.85 %) cases were concordant with National algorithm for syphilis diagnosis. Thirteen (0.13 %) cases were found false positive while two were false negative. The sensitivity of the kit for syphilis diagnosis was found to be 95.45 % (95 % CI 84.86-98.74 %) and specificity was 99.87 % (95 % CI; 99.78-99.92 %). Positive predictive value was 76.36 % (95 % CI; 63.65-85.63 %) and Negative predictive value was 99.89 % (95 % CI; 99.39-99.99 %). Kappa value was found to be 0.85.
conclusionThe performance characteristics of SD Bioline HIV/Syphilis duo kit were found almost concordant with the kits being used for HIV and Syphilis diagnosis separately. Its implementation in antenatal clinics/VCTs could be an added opportunity for simultaneous diagnosis of HIV and syphilis.
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